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510(k) Data Aggregation

    K Number
    K252940

    Validate with FDA (Live)

    Device Name
    VR® Personal Protective Level 3 Gown (VR Gowns)
    Manufacturer
    Polyconversions, Inc.
    Date Cleared
    2025-12-16

    (92 days)

    Product Code
    QPC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VR® Personal Protective Level 3 Gown is intended to protect healthcare patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The VR® Personal Protective Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the VR Gown is open and non-protective. The VR Gown is not intended for use in the operating room.

    Device Description

    Not Found

    AI/ML Overview

    N/A

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